MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM; REUSABLE INSTRUMENTS

Model Number PM431R

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the maryland dissector instrument.After an unspecified gynecological procedure and during decontamination, it was discovered that the connection part of the jaw inserter has been broken.The facility contact was unsure exactly when the malfunction occurred and where the piece was located.It was noted that an x-ray had been taken after the surgery and no indication of the broken part was found.The physician stated that the missing part seemed to be blue ceramic of 1 mm - 2 mm in size; the grey ceramic had cracks but no missing fragments.The physician and staff had been unaware of a malfunction during the procedure.Additional information was not provided.

Manufacturer Narrative

Contact information updated due to expiration of exemption e2014018.Manufacturing site evaluation: investigation: the instrument arrived in a clean status with visible damage.The missing or broken off fragments were not returned.The investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eg.-nr.2000024840) and the digital camera "panasonic dmc tz8".During visual inspection, a loosened blue ceramic part was found.Additionally, the grey ceramic was cracked and a piece was broken off.Further investigation found that the jaws were misaligned and an area of the blue ceramic was also broken off.Batch history review: the device quality and manufacturing records were reviewed for this lot number and found to be according to specifications, valid at the time of manufacturing.No similar reports have been filed for products from this batch.Conclusion and root cause: the root cause of the damage seen is most probably usage related.Rationale: according to the quality standard and dhr files, a production error as well as manufacturing defect can be excluded in this case.Investigation indicates that the ceramic breakages and misaligned jaw parts were caused by improper handling related to a mechanical overload situation.Excessive force, torsion, or high leverage were possibly applied to the instrument.Instructions for use advise against such practices due to the potential for damage such is seen in this case.No manufacturing relationship to the damage of the returned product is established.Corrective action: according to sa-de13-m-4-2-04-000-0 there is no capa necessary.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8689051
• MDR Text Key: 147728678
• Report Number: 9610612-2019-00388
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K001330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM431R
• Device Catalogue Number: PM431R
• Device Lot Number: 61962507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 63 MO
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1