MAUDE Adverse Event Report: RICHARD WOLF GMBH INTESTINE GRASP FORCEPS INSERT 0 5MM

Model Number	8393249
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Perforation (2001); Bowel Perforation (2668)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient remained in hospital for longer than was expected.Rwmic will attempt to obtain additional information from (b)(4) on patient demographics and other missing information.When evaluation results become available, a follow up report will be submitted as appropriate.Rwmic considers this report open at this time.
Event or Problem Description
Richard wolf medical instruments corporation (hereinafter referred to as rwmic) was made aware of an event from richard wolf (b)(4) (hereinafter referred to as (b)(4)) on 8/17/2018.(b)(4) was notified on 7/31/2018 by distributor in (b)(6) of an event that occurred at the hospital on (b)(6) 2018 during a small bowel occlusion surgery.During procedure 7 perforations were noted and determined to be likely caused by manipulation with the forceps.The bowel was uncharacteristic during the procedure and the manipulation was not excessive.The doctor had to set several clamps which had to be removed later.The patient required to stay in hospital longer than expected.
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The examination of the 3 sent in internal parts showed that they product specifications and can be used thus without hesitation.The inner parts have no edges, chamfers or sharp contours.This indicates an error in the use of the device.Type (b)(4) is the inner part of an atraumatically shaped grasping forceps for gripping and manipulating small and large intestine tissue.The inner part of the forceps is designed in such a way that even very sensitive intestinal tissue can be manipulated safely and atraumatically at any time.The probability of the occurrence with regard to the occurrence is to be estimated as low, since so far no such occurrences have been reported to richard wolf gmbh in the last 4 years.When manipulating intestinal tissue, care should be taken not to exert too much pressure on the tissue through the grasping forceps in order to avoid possible injuries.The probability that a tissue injury caused by the product is caused by proper use is unlikely but possible.Richard wolf gmbh considers this case as closed.

• Brand Name: INTESTINE GRASP FORCEPS INSERT 0 5MM
• Common Device Name: INTESTINE GRASP FORCEPS INSERT 0 5MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7824372
• Report Number: 9611102-2018-00012
• Device Sequence Number: 13836886
• Product Code: GCJ
• UDI-Device Identifier: 04055207055731
• UDI-Public: 04055207055731
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8393249
• Device Catalogue Number: 8393249
• Device Lot Number: 4500218267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR