MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER SM 5/310MM; ENDOSCOPY

Model Number PL802R

Device Problem Flaked (1246)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the customer found that the black coating of the handle came off in an operation.The fragments came off the handle was not found.Therefore , there was the possibility of the remains are in the patient.All med watch submissions related to this report are: 9610612-2017-00402, 9610612-2017-00403.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the handle pl503875.Here we found that the screw pl005211 is missing.Additionally we found broken areas on the black rilsan layer and cracks.Additionally we made a visual inspection of the mint green rilsan layer.Here we found more cracks.Conclusion and root cause: the root cause of the problem is most probably design related.Rational: we assume a design error as the causal factor for the breakage and tearing of the rilsan layer.A material change was initiated with change number 52884 for the mint green rilsan layer.A capa was launched and completed (b)(4).Additionally a new capa is applied for the black rilsan layer (b)(4).

• Brand Name: DS-SINGLE FIRE LAP.APPLIER SM 5/310MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6757539
• MDR Text Key: 81516300
• Report Number: 9610612-2017-00402
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL802R
• Device Catalogue Number: PL802R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/27/2017
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other