MAUDE Adverse Event Report: OLYMPUS OLYMPUS; RESECTOSCOPE BRIDGE

Model Number A20976A

Device Problems Crack (1135); Nonstandard Device (1420); Microbial Contamination of Device (2303); Component Missing (2306); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

In (b)(6) 2016, our facility (a (b)(6) hospital) purchased 10 new resectoscopes and components.In early (b)(6), the operating room reported a piece of "bio-burden" was dislodged from a resectoscope.Upon examination of the foreign substance, it was determined to be non-biologic and appeared to be a piece of epoxy" type adhesive.A different set was opened and the "bridge", part number a20976a was examined using a flexible 2mm fiber-optic scope.This showed a crack and lifting of the adhesive.All ten of the bridges were examined and each one had similar problems which would prevent proper cleaning and sterilization of the item.There were multiple bridges that had missing segments of the adhesive.Olympus confirmed that an adhesive was used in the mfg process.All of the sets were removed from service and scheduled cases requiring the use of the olympus resectoscope set were cancelled.(b)(6) was notified and put out a (b)(6) wide alert for other facilities to examine this product.This mfr was also notified of the problem and provided replacement parts.These replacements were examined using the same fiber-optic scope and determined to be intact and safe for use.We were assured us this problem would be examined and the situation corrected including a recall of the affected lots.On march 2, there was a report in sterile processing (sps) of possible rust on one of the bridges.This bridge was examined using a rigid 2.7 mm endoscope (which provides significantly improved resolution).A large crack with a missing portion of the adhesive was observed.An examination of the 8 used a20976a bridges all showed significant failures.These were taken out of service.The lot numbers of the bridges from the (b)(6) purchase are: 162w-0115, 162w-0108, 162w-0109, 162w-0112, 163w-0075, 163w-0117, 163w-0113, 163w-0085, 163w-0114, 163w-0083.The lot numbers for the replacement bridges which failed are: 116w-0082, 116w-0081, 116w-0092, 116w-00094, 116w-0118, 116w-00017, 116w-0005, 116w-00008, 116w-0019.Other older bridges were located which had been kept as back-ups and examined with the rigid endoscope.Some showed a near complete absence of the adhesive - lots 3yw-0095, 08zw-0069, and 097w-0040.Others had more significant amounts of the adhesive remaining, this was lot 147w-0117 (model 20977a).None of the bridges that had been in use for over one month were found to be without damage.The damage to these components makes it impossible to properly clean the bridge.Because many had missing portions of the adhesive.It cannot be resulted out that these pieces were not introduce into the pt.I have been informed by infection control that they have observed an increase in bacteremia in pts who have undergone procedures in which these resectoscopes are used.Based on the identification of issues related to the olympus bridges.Infection control is doing an investigation into this matter involving a look-back of procedures involving the use of olympus resectoscopes since (b)(6) 2016.Photos of all of the current bridges are available (all 166w lots) along with several of the bridges that were kept in storage.This particular item cannot be accurately examined without the assistance of some type of fiberoptic device, making it difficult and time consuming to properly examine this item (the resectoscope set has over 50 components).Concomitant medication is pending, due to the nature of this issue, it is felt early notification is necessary.Affected pts can be provided if necessary.

• Brand Name: OLYMPUS
• Type of Device: RESECTOSCOPE BRIDGE
• Manufacturer (Section D): OLYMPUS; hamberg 22045 DE
• MDR Report Key: 6386873
• MDR Text Key: 69492456
• Report Number: MW5068325
• Device Sequence Number: 10
• Product Code: FJL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2017
• 23 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A20976A
• Device Lot Number: 163W-0083
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention